SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
___________________
Date of Report (Date of earliest event reported) August 19, 1997
BIOCONTROL TECHNOLOGY, INC.
(Exact name of registrant as specified in its charter)
Pennsylvania 0-10822 25-1229323
(State of other jurisdiction (Commission File Number) (IRS Employer
of incorporation) Identification No.)
300 Indian Springs Road, Indiana, Pennsylvania 15701
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (412) 349-1811
_________________________________________________________________
(Former name or former address,
if changes since last report.)
Item 1. Change in Control of Registrant.
Not applicable.
Item 2. Acquisition or Disposition of Assets.
Not applicable.
Item 3. Bankruptcy or Receivership.
Not applicable.
Item 4. Changes in Registrant's Certifying Accountant
Not applicable.
Item 5. Other Events.
On August 19, 1997, Biocontrol Technology, Inc.
(NASDAQ:BICO) announced that the US Food and Drug Administration
(FDA) has approved for marketing the functional electrical
stimulator (FES) which is manufactured by BICO for NeuroControl
Corporation (NeuroControl) of Cleveland, Ohio, the company that
will market the device.
Biocontrol sales from the FES, called the NeuroControl
Freehand System, are expected to generate $1,210,000 total
revenue in 1997 with 1998 bringing increased sales and revenue as
a result of the FDA clearance.
Item 6. Resignation of Registrant's Directors.
Not Applicable
Item 7. Financial Statement, Pro Forma Financial Information
and Exhibits.
(a) Financial Statements and Businesses Acquired - Not
Applicable.
(b) Pro Forma Financial Information - Not Applicable.
(c) Exhibits-Press Release
SIGNATURES
Pursuant to the requirement of the Securities Exchange Act
of 1934, the Registrant has duly caused this Report to be signed
on its behalf by the undersigned hereunto duly authorized.
BIOCONTROL TECHNOLOGY, INC.
by /s/ Fred E. Cooper
Fred E. Cooper, CEO
DATED: August 19, 1997
BICO
BIOCONTROL TECHNOLOGY, INC
2275 Swallow Hill Road, Building 2500
Pittsburgh, PA 15220
Press Release
Release: Immediate
For More Information, Call:
Investors Media
Diane McQuaide
Susan Taylor
1.412.429.0673 phone
1.412.279.9455 phone
1.412.279.9690 fax
1.412.279.9447 fax
FDA APPROVAL GRANTED FOR FES PRODUCT
MANUFACTURED BY BIOCONTROL
Pittsburgh, PA - August 19, 1997 - Biocontrol Technology,
Inc. (Nasdaq:BICO) announced today that the US Food and Drug
Administration (FDA) has approved for marketing the functional
electrical stimulator (FES) which is manufactured by BICO for
NeuroControl Corporation (NeuroControl) of Cleveland, Ohio, the
company that will market the device.
Biocontrol sales from the FES, called the NeuroControl
Freehand System, are expected to generate $1,210,000 total
revenue in 1997 with 1998 bringing increased sales and revenue as
a result of the FDA clearance.
Mr. Ronald Podraza, president and chief executive officer of
NeuroControl Corporation, said, "Biocontrol Technology was
instrumental in obtaining the FDA approval to market the Freehand
System. The devices produced by BICO for our clinical trials
were of the very highest quality and have an outstanding
performance record."
According to NeuroControl, more than 125,000 people with
paralysis from the chest down due to spinal cord injury may
benefit from the Freehand System. Worldwide, their conservative
estimate is that there are over 500,000 people with spinal cord
injury and approximately 25,000 new injuries per year.
The Freehand is surgically implanted beneath the skin to replace
damaged or severed nerves and stimulate muscles through
electrodes by restoring lost motor functions such as hand-
grasping and arm movement.
Biocontrol has been manufacturing the device since 1990 when
it began working on the FES research with Case Western Reserve
University. When NeuroControl assumed commercialization of the
FES technology in 1995, Biocontrol was retained as the
manufacturer. The companies are conducting negotiations for a
long-term business arrangement which would assure NeuroControl a
steady supply of the implantable stimulators for at least seven
years.
Biocontrol Technology, Inc. has its corporate offices in
Pittsburgh, PA and is involved in
the development and manufacture of biomedical devices and
environmental products.
